Kristine Tatsutani

CSO at R2 Technologies, Inc. | Leading Clinical and Regulatory Strategy

United States

About

Chief Science Officer with 25+ years of experience leading scientific, clinical, regulatory, and quality programs across the full medical device product lifecycle. Brings deep expertise in defining scientific and clinical research strategies to align technology development with regulatory pathways and drive adoption across multiple technologies and diverse therapeutic areas. Provides strategic leadership and hands-on execution of clinical programs spanning early feasibility studies, pre-market regulatory trials, post-market evidence generation, and medical engagement initiatives that strengthen value propositions for key stakeholders. Proven ability to build and lead high-performing, cross-functional teams to deliver results under aggressive timelines and advance corporate objectives. Leads with integrity, authenticity, and empathy, and believes the strongest innovations emerge at the intersection of scientific rigor, collaborative leadership, and a growth mindset. Deeply committed to developing talent, building trusted partnerships, and advancing healthcare through evidence-driven, patient-centered innovation.

Experience

  • CSO at R2 Technologies, Inc.
    Mar 2015 - Present · 11 yrs 4 mos

    - Defined scientific and clinical strategy for a dermatology device platform, guiding products from early development through global commercialization. - Built and led Clinical Affairs, Clinical Education, R&D, Regulatory Affairs, and Quality teams. - Designed and oversaw first-in-human, pivotal, and post-market clinical programs supporting FDA clearances, indication expansion, and market adoption. - Led regulatory strategy and submissions across North America, EU/UK, LATAM, APAC, and the Middle East. - Managed R&D through development and launch of first commercial products in North America and China

  • VP, Clinical and Regulatory Affairs at Arrinex, Inc. (concurrent position)
    Jan 2014 - Oct 2017 · 3 yrs 10 mos

    - Created clinical and regulatory plan for early-stage company developing endoscopically guided neuromodulation device - Designed and executed pivotal clinical study leading to FDA clearance for treatment of chronic rhinitis

  • Chief Science & Technology Officer & Sr. VP Clinical, Quality, and Regulatory at Zeltiq Aesthetics
    May 2011 - Dec 2014 · 3 yrs 8 mos

    - Member of executive leadership team that launched novel non-invasive body contouring device - Defined and executed clinical research programs to optimize treatment protocols, expand product indications, strengthen clinical evidence, and drive customer adoption - Established and executed global regulatory strategies, overseeing submissions that enabled international market expansion - Led advanced technologies engineering group to deliver product innovations to fuel portfolio growth

  • VP, Clinical & Scientific Development at MyoScience
    2008 - Apr 2011 · 3 yrs 4 mos

    - Directed preclinical and clinical evaluation of neuroablation device for interventional pain management - Developed clinical trial strategies to support commercialization; built and led clinical affairs team - Established on site clinic to facilitate execution of clinical studies and procedure optimization

  • Research Fellow at Boston Scientific
    2005 - 2008 · 3 yrs

    - Provided research leadership for development of pulmonary vein isolation catheter for treatment of atrial fibrillation